Drugmaker’s dual role as friend, foe

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If you’re inclined to be cynical about corporations in general, and about the pharmaceutical industry in particular, the company behind Zohydro is your Exhibit A.

Zohydro ER is the powerful new painkiller that has people on the front lines of the opioid abuse epidemic freaking out, because the high-dose drug is more easily abused than other painkillers and more deadly if you take too much. Some in Congress and 28 attorneys general want the FDA to reverse its approval of the drug, an approval that defied the recommendation of the agency’s scientific advisory panel. Last week, Governor Deval Patrick imposed a ban on Zohydro until a safer form is developed. On Tuesday, a federal judge indicated she would strike down that ban.

Out front in all of this controversy has been a company called Zogenix, out of San Diego. But Zogenix has only a license to market the drug. The actual outfit behind Zohydro is a Waltham company named Alkermes, which acquired Zohydro when it bought an Irish pharmaceutical company a few years ago. Zogenix markets the drug and takes heat from critics, but Alkermes owns Zohydro, manufactures it, and stands to make mountains of money from it.

It also stands to sacrifice its image as a hero to the addiction treatment community.

Until now, Alkermes has been greatly admired as the manufacturer of a drug called Vivitrol, a monthly injection that makes it less likely recovering addicts will relapse. It’s widely used in treatment centers and is administered to inmates preparing to leave jails in three counties in Massachusetts. Vivitrol is headed for use in the state correction system, too. The company has relished this healing role and helps to fund the American Society of Addiction Medicine, based in Maryland.

With Zohydro, Alkermes will be profiting from the other side of the addiction equation, too. A lot of people are very upset about this, with good cause.

Doctors prescribe way too many powerful painkillers in this country. The skyrocketing overdoses are mirrored by rising prescriptions for Oxycodone, Vicodin, and other opioids, especially for middle-aged people in chronic pain. Adding another powerful painkiller to an already saturated market, especially one that is easily crushed and snorted, means more prescriptions, more abuse, and, inevitably, more deaths.

‘I was shocked they [Alkermes] would be involved in creating the potential for a worse epidemic.’

“I’m appalled,” said Andrew Kolodny, chief medical officer of Phoenix House, a national addiction treatment network with six centers in Massachusetts. “I think it’s disgusting that a drug company with an opioid addiction treatment would want to grab a piece of the legal narcotics trade.”

Former state senator Steven Tolman was once a huge fan of Alkermes and its president, Richard Pops. A leader on substance abuse issues in 17 years on Beacon Hill, Tolman sang Alkermes’ praises to his colleagues, to law enforcement, “to anybody who would listen, frankly.” Now, the company that worked for years with Tolman and others to help people addicted to opioids turn their lives around is producing not just any opioid, but one that could be a disaster for addicts.

“I was shocked they would be involved in creating the potential for a worse epidemic,” said Tolman, who now heads the state AFL-CIO. “I thought they were the best thing since sliced bread. Now I’m sick to my stomach.”

US Representative Bill Keating’s district in the state’s southeast has been one of the hardest-hit by overdoses. He says Zohydro proves that Alkermes is motivated not by “the mission of preventing the carnage that comes from the use and abuse of these drugs, but rather the bottom line.”

“It’s a company, and its mission is to create profits,” he said. “But I’ll tell you this, the profits in many instances are at the expense of ruined and lost lives.”

It’s no news flash that a pharmaceutical company is motivated by profit. Free enterprise is what made America great, and all that jazz. Jenny Craig has every right, if it chooses, to open up doughnut shops next door to its weight loss centers. And the pharmaceutical industry has always walked a fine ethical line: treating people’s pain, and profiting from it.

But even in the context of those realities, Alkermes’ turn down this dark path is unseemly at best and grimy at worst, not to mention disheartening.

Alkermes spokeswoman Jennifer Snyder issued a statement yesterday that seemed to distance the company from Zohydro, or at least from the outcry over it.

“Alkermes is proud of the role we play in helping people with substance abuse disorders with Vivitrol [naltrexone], a medicine that we developed, own and market,” it read. “Our core business is focused on the development of important medicines for serious chronic diseases, such as mental illness, addictive disorders and depression.”

Zohydro came as one of more than 20 drugs Alkermes acquired when it bought the other company, and “we do not intend to be the long-term manufacturer of hydrocodone products,” the statement went on, adding that the company is developing a new pain medication “with intrinsically low potential for abuse and overdose.”

That may take a while. In the meantime, Alkermes’ rivals may overtake it. Last month, Connecticut-based Purdue Pharma announced that it had successfully tested a tamper-resistant form of hydrocodone, the active ingredient in Zohydro. If Purdue’s drug comes to the market, Zohydro in its current form is likely to be removed.

So, the folks at Alkermes may have white hats forced back on their heads. They had better hope their former fans have short memories.